Last Updated: November 8, 2026

Details for New Drug Application (NDA): 215336

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NDA 215336 describes LEUPROLIDE ACETATE, which is a drug marketed by Amneal, Eugia Pharma, Genzyme, Meitheal, Ph Health, Sandoz, Somerset Theraps Llc, Sun Pharm, UBI, Zydus Pharms, and Invagen Pharms, and is included in eleven NDAs. It is available from eleven suppliers. Additional details are available on the LEUPROLIDE ACETATE profile page.

The generic ingredient in LEUPROLIDE ACETATE is leuprolide acetate. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.

Summary for 215336

Tradename:	LEUPROLIDE ACETATE
Applicant:	Amneal
Ingredient:	leuprolide acetate
Patents:	0

Medical Subject Heading (MeSH) Categories for 215336

Antineoplastic Agents, Hormonal
Fertility Agents, Female

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	14MG/2.8ML (1MG/0.2ML)
Approval Date:	Oct 28, 2022	TE:	AP	RLD:	No

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